Z-0192-2023 Class II Ongoing

Recalled by Cardinal Health 200, LLC — Waukegan, IL

Recall Details

Product Type
Devices
Report Date
November 16, 2022
Initiation Date
September 28, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
129412 units

Product Description

Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A

Reason for Recall

Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .

Distribution Pattern

nationwide and Canada

Code Information

UDI/DI (01)30888499004898, All lots